A&D UB-1100BLE
Device Model:
UB-1100BLE
Manufacturer:
A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Australia and United States
Description:
The A&D UB-1100BLE is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the A&D UB-1100BLE, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Stride BP | Self-measurement for adults | Equivalence claim without published evidence |
| Consumer Body | Year(s) | Level | Comment | |
| BP | Consumer Reports (US) | Latest: 2021 | Fair |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
A&D UB-543
Fania C, Benetti E, Palatini P. Validation of the A&D BP UB-543 wrist device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Aug;20(4):237-40. Epub: 2015 Mar 12. doi: 10.1097/MBP.0000000000000117. PMID: 25768063.
ESH-IP:2010 - Pass General population